The authors describe a method-validation-by-design (MVbD) approach to validate a method over a range of formulations using both design-of-experiment and quality-by-design principles to define a design ...

Nonclinical dose formulation analysis methods are used to confirm test article concentration and homogeneity in formulations and determine formulation stability in support of regulated nonclinical ...

A new nanomedicine formulation method that uses the active pharmaceutical ingredient (API) as a scaffold rather than a separate matrix is a big breakthrough for biopharmaceutical manufacturers, says ...

As sponsors advanced more niche and personalized modalities, manufacturers were pushed to adopt holistic approaches to safety ...

In the ever-evolving field of pharmaceuticals, continuous innovation is key to developing new drug delivery systems that can improve patient outcomes and increase therapeutic efficacy. One such ...

Patients with some cancers, autoimmune diseases, and metabolic disorders often endure time-consuming intravenous (IV) infusions to receive the best protein-based treatments available. Because these ...

Discover how businesses calculate depreciation to account for asset value loss over time, with methods including ...